Regulatory Operations Specialist / Regulatory Data Management (Contract)

*W2 candidates only- Green card and US citizen status*

📍 Onsite - Princeton, NJ (Potential hybrid schedule 3x/week later)
⏳ 12+ Month Contract
💰 Up to $51.50/hr (W2)

We are seeking an experienced Regulatory Operations / Regulatory Data Management professional to support global regulatory activities in a highly visible, long‑term contract role. This position plays a critical role in maintaining regulatory readiness, ensuring data integrity, and supporting global submissions through robust Regulatory Information Management Systems (RIMS).

What You'll Do

• Manage and maintain accurate regulatory data within RIMS to support global regulatory strategies and compliance
• Perform regulatory submission, document, and data uploads, verification, and linkage within the system
• Generate RIMS reports to support regulatory strategy, KPIs, and operational needs
• Map regulatory correspondence and submissions accurately and partner with global regulatory teams to ensure proper filing
• Develop, update, and continuously improve global SOPs, work instructions, and process controls
• Support regulatory operations activities including:
  • Device establishment registrations
  • Device listings
  • Global UDI systems (FDA GUDID, EUDAMED, AUSUID, etc.)
  • Electronic publishing
• Collaborate cross‑functionally to enhance systems, processes, and inspection‑ready documentation
• Support regulatory intelligence, publishing, and data governance initiatives as needed

Required Experience & Skills

• 4-6 years of experience in Regulatory Operations or Regulatory Data Management
• Hands‑on experience with RIMS and regulatory data governance platforms (e.g., Veeva Vault, Agile)
• Strong understanding of FDA regulations and international regulatory requirements
• Experience with regulatory submission formats (eStar, eCTD, paper submissions)
• Background in SOP authoring, execution, and process documentation
• Exposure to process automation, dashboards, or analytics tools (Power BI, Tableau preferred)
• Bachelor's degree required
• Strong attention to detail, documentation accuracy, and compliance

Why This Role

• Long‑term contract with strong visibility and impact
• Opportunity to work with global regulatory teams
• Hands‑on ownership of regulatory systems and data
• Potential hybrid flexibility after onboarding period

👉 Interested? Apply directly or message me to learn more.